Clinical Data Manager

Role: Clinical Data Manager supporting Viking Therapeutics' obesity and metabolic disease clinical trials. Responsibilities: oversee CRO Data Management activities, develop study documentation, design and maintain EDC/IRT/ePRO systems, create data review strategies, coordinate data transfers, and ensure compliance with GxP, ICH, CDISC, 21 CFR Part 11, and FDA guidelines. Collaborate cross-functionally with Clinical Operations, Safety, Biostatistics, and external vendors; monitor study progress, manage risk, and facilitate timely database lock. Requirements: minimum 2 years in Clinical Data Management, Bachelor's in a scientific or medical field, experience in clinical data systems and review plans, plus managing multiple projects. Preferred: Phase 3 trial experience. HighValue: clinical trials (likely Phase 2/3) in obesity/metabolic disorders; expertise in EDC/IRT/ePRO platforms; regulatory compliance (GxP, FDA). WorkSetup: not specified.